Lean Six Sigma for Intravenous Therapy Optimization: A Hospital Use of Lean Thinking to Improve Occlusion Management - Nexus ...
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O R I G I N A L A R T I C L E Lean Six Sigma for Intravenous Therapy Optimization: A Hospital Use of Lean Thinking to Improve Occlusion Management Lee Steere, RN, CRNI, VA-BC Marc Rousseau, MBA, RPH Lisa Durland, MS, RPH Hartford Hospital, Hartford, CT Abstract Background: Continual improvement is a necessary part of hospital culture. This occurs by identifying opportunities for improvement that influence efficiency while saving money. Methodology: An investigation of intravenous device-related practices was performed by the nurses of the intravenous access team, pharmacy, and hospital operations at Hartford Hospital using Lean Six Sigma methodology. Central venous access device occlusion and tissue plasminogen activator variability was identified. Using observation, measurement of performance, and root cause analysis, the hospital’s practices, policies, and equipment were evaluated for the process of occlusion management. The team utilized a Six Sigma strategy employing the elements define, measure, analyze, improve, and control, which is a disciplined, data-driven methodology that focuses on eliminating defects (waste). Interventions initiated based on the assessment performed by the team using the define, measure, analyze, improve, and control approach included replacement of negative displacement needleless connectors with antireflux needleless connectors and specialty team assessment before tissue plasminogen activator use. Results: Over the course of the 26-month study, Hartford Hospital experienced a 69% total reduction in tissue plasminogen activator use representing a total 26-month savings of $107,315. Other cost savings were reflected in areas of flushing, flushing disposables, and in a decrease in needleless connector consumption. Central line-associated bloodstream rates fell 36% following the intervention as an unexpected secondary gain, resulting in further savings related to treating this nonreimbursable hospital-acquired condition. Conclusions: This study examined the influence of using Lean Thinking and Six Sigma methodology as a tool in saving hospital money, resulting in better patient outcomes. Keywords: central venous catheter, cost savings, lean six sigma Introduction time during the IV treatment processes.7,8 Intraluminal throm- A mong the most frequent complications associated with botic catheter occlusion, a common noninfectious complication, central venous access devices (CVADs) is catheter oc- is associated with negative outcomes of loss of patency (43%), clusion, ranging from 3%-79%.1-4 Thrombotic formations device replacement (29%), device removal (14%), and hospi- on a CVAD are a natural physiological process in response to tal visits (15%) that all delay or disrupt the treatment process, the insertion of foreign material into the body. Immediately upon slow a patient’s progress toward therapeutic goals, and in- insertion of an intravenous (IV) catheter, cells attach to the surface crease length of hospital stay and cost of care.1,2,9,10 forming a fibrin coating.5,6 This body response occurs soon after Peripherally inserted central catheters (PICCs), a type of insertion and may develop around and within a catheter at any CVAD, have a higher incidence of occlusion than other chest- inserted central catheters potentially due to factors such as insertion into smaller peripheral veins, larger surface area, use of 3F-6F sizes with multiple lumens, and small catheter Correspondence concerning this article should be addressed to diameter.2,11-16 Activities associated with PICCs for administra- Lee.Steere@hhchealth.org. tion of IV medications and solutions require flushing, aspiration https://doi.org/10.1016/j.java.2018.01.002 of blood, and connection and disconnection of needleless con- Copyright © 2018 Association for Vascular Access. Published nectors (NCs) causing pressure changes within the catheter that by Elsevier Inc. All rights reserved. result in venous blood cell deposits within the lumen of the 42 | JAVA | Vol 23 No 1 | 2018
catheter known as reflux. Reflux is associated with both me- • Control by building a system of checks and adjustments chanical and physiological pressure changes that force blood for ongoing improvement in the process, protocols, prac- into the catheter lumen, leaving blood deposits contributing to tices, products, and patient outcomes (5Ps) of IV therapy. the incidence of catheter occlusion.17,18 Reflux of blood into the terminal end of a catheter is a cause The Hartford IV Team and stakeholders incorporated inves- of catheter occlusion.19 Patient movements, muscle flexing, and tigation of the 5Ps of IV therapy for insertion and management coughing all cause pressure changes and reflux within the cath- of vascular access devices. This process used the 5Ps as a tool eter. As the catheter is manipulated, blood is intermittently pulled to assist in differentiating value-added actions from nonvalue- back into the catheter.19,20 These deposits of blood on the cath- added actions. By using the 5Ps systematic approach, waste and eter may be cleared, somewhat, with saline flushing.21-23 When variability became obvious and detectable. catheter lumen flushing is inadequate or blood protein depos- The LSS program at Hartford continued with agreement from its completely or partially block the terminal end of the catheter, the stakeholders from the supply chain and IV Team and from these occlusions to the terminal end of the catheter may prevent pharmacy, all committed to performance improvement. Infu- blood sampling and the infusion of fluids.10,21,24,25 sion treatment with catheters in our facility represents more than 90% of our acute care hospital patients and CVADs are in use in approximately 50% of intensive care patients. Evaluating Lean Six Sigma CVAD occlusion in terms of catheter function, flushing, and Hartford Hospital in Hartford, Connecticut, is an 867-bed re- reflux had the potential to speed treatment and reduce occlu- gional referral center and the largest Hospital in the Hartford sion complications. Wasted time, money, medical supplies, and Health System. Lean Thinking and Six Sigma are 2 process im- pharmaceuticals and medications as well as logistics and nursing provement methods the IV Team at Hartford Hospital costs were all components because they applied to reported events implemented to improve infusion therapy practices. The Lean of occlusion. LSS focuses on reducing defects, variability, and Six Sigma (LSS) process is used to implement positive change waste in current hospital IV access device practices. by identifying inefficiencies, variables, process defects, and waste.26-31 Specifically, LSS is a quality improvement method- Methods ology that originated during the 1970s with the Toyota Motor The LSS methodology was used with the design indicated Company and Toyota Production System.32 Much of the Toyota by the DMAIC process to define problems and goals, measure Production System way of thinking is based on the work of W. activities and supplies, analyze results, and devise improve- Edwards Deming.33 Deming taught, among other things, that ment strategies based on analysis and control throughout the managers should stop depending on mass inspection to achieve process. A team of clinicians trained in LSS evaluated proce- quality, and instead focus on improving the production process, dures from October 2014 to December 2016 to identify problems, protocols, practices, and building quality into the product in the set goals to improve patient outcomes and reduce variability and first place. LSS strives to pinpoint quality processes that correct waste resulting in long-term economic change. Goals and ob- identified defects in a system. Simply put, LSS means using less jectives for each patient outcome and the variability and waste to do more. sections were established for CVAD use, including heparin flush- The Lean Thinking concept was used initially in our depart- ing, occlusion management, medication administration, CVAD ment to improve the management of occluded CVADs. The replacement, and all associated supply costs. hospital chose to study CVAD occlusion management while working to promote savings in medications, supplies, and time. DMAIC Phases This process allowed identification of variables that influ- The LSS framework for infusion therapy practices at our fa- enced the way occlusions were managed (ie, assessment of cility began with a set of value-added actions and improvements catheter function) and implement corrective actions that im- identified through the DMAIC process. The DMAIC method proved patient delivery of treatment without administering was applied over 26 months as described in Tables 1–5. During unnecessary medications. the define phase (Table 1), products and patient outcomes were The LSS data-driven quality method at Hartford Hospital was evaluated for IV therapy. A refined literature review delved into specifically guided by a programmed approach: defining, mea- subjects of catheter patency; thrombotic occlusion; risks asso- suring, analyzing, improving, and controlling (DMAIC).34-36 ciated with tissue plasminogen activator (tPA) use; blood reflux; The DMAIC phases: NCs; valves used in catheters and NCs; flush solution volume and frequency; and CVAD indications, appropriate use, and tip • Define opportunity for improvement, project goals, and position.10,17,20-22,37-51 The results of the literature review as- patient requirements. sisted in guiding the analysis process.52,53 After defining key • Measure pharmacy and medical supply consumption, concepts and associated activities the process moved into the overall cost, and performance. measurement phase. • Analyze the consumption data to determine root causes The measure phase (Table 2) of DMAIC distinguishes spe- of variation and poor performance (defects). cific goals that quantify practices and processes needing • Improve process performance by addressing and elimi- improvement. Measurement key areas included incidence of oc- nating the root causes. clusion; drug use for occluded catheters; supply consumption 2018 | Vol 23 No 1 | JAVA | 43
Table 1. Phase I: Define Table 3. Phase III: Analysisa 1. Goals and objectives: Improve patient care, improve Analyze all data collected and map potential performance patient outcomes, reduce waste, reduce IV variability, and opportunities improve long-term economic results Review new needleless connector technology 2. Define and review IV therapy 5Ps (IV processes, IV Review literature regarding needleless connectors protocols, IV practices, IV products, and IV patient outcomes) Review infusion therapy evidence 3. Identify and target a specific hospital area (inpatient acute Root cause analysis of tissue plasminogen activator use by care areas) where peripherally inserted central catheter registered nurses in intensive care unit and central venous access devices are inserted and used Registered nurses using tissue plasminogen activator 4. Focus on reducing pharmacy and medical supply waste without identifying cause of occlusion by: Prioritize opportunities to improve a. Tissue plasminogen activator/tissue plasminogen acti- vator use and associated cost, IV = Intravenous. a b. Flushing with heparin, Look for signs of IV waste, IV variability, and root causes of defects in our c. Replacement and other costs associated with peripher- 5Ps. ally inserted central catheters and central venous access devices, and In the analysis phase (Table 3), information obtained during d. Reducing medical supply consumption and medical supply the measure phase was mapped to demonstrate performance im- costs provement opportunities as they applied to PICCs and all other CVADs. Root cause analysis of each occurrence of CVAD oc- IV = Intravenous. clusion incorporated the 5Ps. Each identified occlusion event was accompanied by use of a thrombolytic medication (Cathflo; specific to NCs; catheter volume and line days; and influence Genentech Laboratories, San Francisco, CA). Heparin and saline on central line-associated bloodstream infections (CLABSIs). flushing practices, NC use, and associated supplies were in- NCs and add-on peripheral supplies were also evaluated and cluded in the analysis. Understanding the outcomes of occlusion quantified. The NCs in use at our facility included a negative and subsequent complications led researchers to establish an im- displacement valve (Clave; ICU Medical, Inc, San Clemente, plementation plan that resulted in improvement. CA). Collection of data, performed by the LSS clinicians and IV Team, established baseline levels for improvement, com- Table 4. Phase IV: Improvea parison, and analysis. 1. All nontunneled central venous access device catheters shall be effectively assessed by a trained and skilled IV Table 2. Phase II: Measurea Team RN for thrombotic occlusion before tissue plasminogen activator is ordered 1. Obtained alteplase/tissue plasminogen activator consumption data from pharmacy department 2. Nontunneled Central Venous Access Device Patency Assessment Algorithm/Check List will be used to 2. Obtained prefilled heparin flushing syringe consumption determine root cause of occlusions data 3. IV Team will receive all orders from intensive care nurses 3. Reviewed alteplase/tissue plasminogen activator and so proper and effective assessments can be achieved by a heparin flushing 5Ps trained and skilled IV Team RN 4. IV Team began receiving daily tissue plasminogen 4. IV Team RN will order tissue plasminogen activator if activator consumption report from pharmacy department appropriate 5. Obtained central line-associated bloodstream infection 5. Eliminate prefilled maintenance heparin flushing with rates since 2007 evidence-based outcomes 6. Obtained central line days since 2007 data 6. Implement use of Anti-Reflux NC to reduce unintentional 7. Obtained needleless connector consumption data blood reflux into peripherally inserted central catheter and central venous access devices and the associated risk of IV = Intravenous. central line-associated bloodstream infection a We measured the 5Ps (IV processes, IV protocols, IV practices, IV prod- ucts, and IV patient outcomes) against our defined goals and objectives VAT = Vascular access team. a to determine our current performance and quantify improvement Improve processes, protocols, practices, and products to eliminate waste, opportunities. variability, and defects to improve patient care and outcomes. 44 | JAVA | Vol 23 No 1 | 2018
Table 5. Phase V: Controla antireflux NCs (Nexus Medical TKO-6P; Nexus Medical LLC, Lenexa, KS) designed to promote long-term patency.47 Out- 1. Nontunneled Central Venous Access Device Patency comes based on the antireflux NC change were reduced occlusion Assessment Algorithm/Check List continues to deliver the and NC supply consumption. Each of these improvement mea- control necessary to sustain the tissue plasminogen sures was projected to influence and reduce incidence of not activator use reduction, improvement in patient outcomes, only occlusion, but also CLABSIs, reduce delays in treatment and hospital economics of occluded catheters, and improve patient satisfaction by re- ducing anxiety associated with nonfunctional CVADs. 2. The antireflux needleless connector automatically provides In the control phase (Table 5), processes were applied to all blood reflux protection to sustain the heparin and 5Ps to improve performance. The control process included imple- corresponding tissue plasminogen activator use menting an electronic medical record ordering process for tPA reductions that improve patient care and hospital that was hidden from view and application of an algorithm economics (Figure: Process Control for Occlusion Management) to eval- 3. Unintentional blood reflux is controlled via use of uate all CVAD occlusions. Over the 26-month period, all antireflux needleless connector and the risk of infection stakeholders adopted these value-added actions and improve- and central line-associated bloodstream infection is ments to maximize care practices for patients with IV access reduced devices at Hartford Hospital. a Control processes, protocols, practices, and products to eliminate waste, variability, and defects to improve patient care and outcomes. Results The number of inpatient acute care patients with CVAD oc- clusions treated with tPA averaged 119 per month during 2014. The improve phase (Table 4) addressed the specific practice Following implementation of an algorithm for appropriate use, measures designed to meet the goals through the 5Ps. These mea- IV Team assessment, and antireflux NCs, the hospital achieved sures included CVAD occlusion evaluation by the IV team before a 56% reduction to a new average annual baseline of 53 oc- use of any thrombolytic medication. Compliance with flushing clusions per month for 2015. Further, the hospital achieved a practices was measured as part of the processes instituted in the 61% reduction in tPA use for occlusions to a new average annual previous phase. Negative displacement NCs were replaced with baseline of 47 occlusions per month for 2016 (Table 6). The Table 6. Baseline 2014 With Negative Displacement Connector Changing to Anti-Reflux Connector 2015-2016 140 120 [VALUE] 2014 Average Baseline tPA Consumption 119/mth for Negative Displacement NC's AVG 100 2015 Average Monthly tPA Consumption 53.18 for a 56% overall reduction from 2014 Baseline 80 TPA USAGE 2016 Average Monthly tPA Consumption 47.5 for a 61% overall reduction from 2014 Baseline 60 60 58 55 59 40 [VALUE] 46 47 45 AVG 51 42 38 37 31 20 0 BaselineBaseline Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec 2014 2015 2016 2016 2016 2016 2016 2016 2016 2016 2016 2016 2016 2016 2018 | Vol 23 No 1 | JAVA | 45
Figure. Process flow for occlusion management. monthly range reflected a low of 31 occulusions per month to tion of 66,100 NCs (Table 7). The results of decreased occlusion, high of 60 occlusions per month. Decreased tPA consumption lower tPA use, and different NCs resulted in a positive annual (at a cost of $65 per 1-mg dose) resulted in savings for 2015 savings of $100,670. Antireflux NCs have been validated for a of $51,480 per year and for 2016 of $55,835 per year. Over the full 7-day use, rather than the twice-a-week change associated course of the 26-month study, Hartford Hospital experienced with the NC our facility previously used. This resulted in less a 69% total reduction in tPA use, representing a total 26- product use, less frequent CVAD line opening, and overall fewer month savings of $107,315 (Table 6). catheter occlusions. Following the intervention of new NCs there was a sus- Flushing practices were reported from October 2014 through tained medical supply reduction of 38%. The antireflux NCs December 2016. Heparin flush use volume at baseline (2014) showed a consumption reduction of 41%, which represented an was 52,522 syringes at a cost of $0.55 per syringe. Heparin annual decrease of 44,493 NCs. Costs associated with the pre- flush syringes were eliminated from the protocol while vious negative displacement connector was $105,064 annually prefilled 10-mL saline flush syringes remain. The elimination with a total consumption of 110,593 NCs. The replacement of heparin flushing syringes resulted in savings of $28,887 antireflux NCs cost $111,709 annually with a total consump- annually. 46 | JAVA | Vol 23 No 1 | 2018
Table 7. tPA Usage Baseline 2014 with Negative Displacement Connector Changing to Anti-Reflux Connector 2015-2016 In addition, the incidence of CLABSI as a secondary end point interruption16,54; negatively affects patient, clinical staff, and phar- was evaluated. Retrospective data were combined with CLABSI macy staff; and results in economic loss for hospital results to reflect decreasing incidence from 2007 to 2016. Eval- administration. Controls, such as assessment of catheter and in- uation of the hospital intensive care unit CLABSI rate identified sertion sites by vascular access specialists; use of an algorithm reductions from a 2007 calendar year high of 39 CLABSIs to to properly troubleshoot reported occlusions; instillation of tPA a low of 9 CLABSIs in 2016. This change in CLABSIs repre- only after careful assessment by vascular access specialists; and sented a 77% decline over 9 years. Even more notable, the ongoing education of clinical staff for productive flushing, ap- hospital’s overall safety score fell from 0.475 to 0.301, a 36% plication of infection prevention measures, and aseptic technique reduction, well below the national average of 0.437. for device management all worked together to improve patient outcomes and reduce risk. Using a focused approach to process Discussion improvement by combining Lean Thinking and Six Sigma, Hart- Concerns over patient outcomes and the promotion of a culture ford Hospital achieved an increase in positive outcomes. of safety drove Hartford Hospital to examine processes, pro- Improvement represented by this initiative was sustained re- tocols, practices, and products along with outcome data collection. duction in CVAD occlusions and tPA use. Sustained improvement Ongoing patient and catheter complications resulted in cathe- is supported by methods instituted by the IV Team. During this ter failure, including occlusion, phlebitis, and infection. These intervention the focus was on 3 key drivers: patient satisfaction, complications influenced function and efficacy in the delivery quality, and improvement. One measure of those drivers was the of treatment and thus were targeted by our facility’s LSS health amount of tPA used during the prior 24 hours. The IV Team re- care initiative. The findings from the LSS DMAIC reflected areas viewed every dose of tPA given via performance of an abbreviated of variability in CVAD occlusion management, NCs, flushing root cause analysis. The IV Team verified that the algorithm had with heparin, and incidence of CLABSI. been applied and if not, the Team investigated the deviation. Application of LSS identified specific components of the Reasons for tPA administration was documented on a Pareto Chart patient care process that were costly roadblocks to success. Cath- (depicting the frequency with which certain events occur), which eter failure influences the ability to deliver treatment without allows better analysis of certain areas needing improvement. The 2018 | Vol 23 No 1 | JAVA | 47
Timeline 1. Calendar Year Analysis and Interventions 2007 to 2016 Needleless Connector Change to An-Reflux, VAT all CVAD Dressings, Heparin Alcohol Disinfecon Caps, Competency & Compliance Audits 39 HAI Commiee Formed - Policy Review and Analysis 40 VAT CVAD Removals, Phlebotomy Training for Blood Cultures CVAD Rounding, Huddles, Eyes on Lines, Educaon Quality Measures Changed to VAP, Rounding Reduced 37 36 35 34 Anmicrobial Dressing, CVAD Dressing Kits CVAD Inseron Check List, IP Educaon Crical Care-Catheter Related Blood Stream Infections CVAD Rounding Resumed, USGPIV Training 30 30 Educaon. EPIC EMR Launched 25 Number of Infecons 20 17 16 Eliminaon 15 15 13 10 9 5 0 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 Catheter Days 18,997 20,932 21,196 20,287 16,399 14,857 15,002 14,004 IV Team at Hartford Hospital continues to meet at 7:15 AM daily toring. This major change in hospital computer systems influenced for a Lean huddle. Every idea generated by the staff of the IV the protocol and ordering process for tPA. There was concern that Team is considered as a possible LSS project. our tPA use would rise, but initiatives hardwired during the LSS The NC change and heparin elimination have continued to result phases were consistently maintained. No increase in tPA use re- in reductions in CLABSI. CLABSI risk factors are multimodal, sulted from the changes in the electronic medical record. The IV with risk at insertion and during management of CVADs. CLABSI Team continued to directly monitor tPA use daily, focusing on reduction initiatives began at Hartford Hospital in 2007 with CVAD why was it given, interventions performed prior, and who is or- rounding, huddles, and an Eyes on CVADs campaign. Founda- dering. Education of bedside nurses was instituted to improve tional principles of a central line bundle consistent with practices that prevented occlusion. Education included training recommendations were applied through hospital education of productive flushing with a push pause action that creates tur- programs.55-57 After instituting education from 2007-2012, con- bulence and greater flush volume as needed. Bedside staff became cerns over NC contamination were expressed as potentially accustomed to the new flushing practice and members of the IV occurring during flushing practices, resulting in NC coloniza- Team evaluating catheter function before ordering of tPA. The tion. Alcohol disinfection caps have been in use since 2010, bedside clinical staff has expressed appreciation for the IV Team including compliance audits, but CLABSI rates spiked in 2012. efforts to help with troubleshooting occlusions, reducing medi- Occlusion in conjunction with blood reflux and NCs had not been cation administration delays and time spent with assessment, thus considered as a risk factor despite the connection between throm- giving clinicians more time to focus on taking care of patients. botic occlusion and infection.58,59 In 1 study,41 the relative risk of CLABSI associated with tPA use was 3 times that of patients who Limitations did not receive tPA. Although there were variables and limita- This study has several limitations. First, the retrospective nature tions within the study period, the results suggest that the subsequent of the data collection for baseline results may reflect inaccu- change to antireflux NCs and limited tPA use resulted in CLABSI racies inherent in retrospective reviews. Measurement and reduction to a low of 9 infections in the critical care unit for 2016. tabulation of results were from methods that incorporated Continued research is needed to completely evaluate the influ- individual input, supply consumption data from material con- ence of reflux and tPA on infection risk within CVADs. sumption and replacement of product, computer results of use Hartford Hospital transitioned into a new electronic medical within pharmacy distribution, and a period of years where com- record system during August 2016. With this transition, there was puter upgrades and software changes may compound a temporary reduction in data input and control over tPA use moni- inaccuracies. Second, variables with multiple interventions in- 48 | JAVA | Vol 23 No 1 | 2018
stituted and overlapping resulted in an inability to clearly indicate 9. Gorski L, Perucca R, Hunter M. Central venous access the intervention and its direct influence. A series of interven- devices: care, maintenance, and potential complications. In: tions initiated by the Healthcare Acquired Infection Committee Infusion Nursing: An Evidence-Based Approach. 3rd ed. occurred during the application of the LSS process. Variables St Louis, MO: Saunders/Elsevier; 2010:495-515. were reduced during the final 2 years as the IV Team took more 10. Hadaway L. Major thrombotic and nonthrombotic direct responsibility for interventions and activities of assess- complications. Loss of patency. J Intraven Nurs. ment, dressing changes, and complications management. 1998;21(suppl 5):S143-S160. 11. Valbousquet Schneider L, Duron S, Arnaud FX, et al. Conclusions Evaluation of PICC complications in orthopedic inpatients This Lean Thinking process with application of the Six Sigma with bone infection for long-term intravenous antibiotics DMAIC and 5Ps principles resulted in significant sustained im- therapy. J Vasc Access. 2015;16:299-308. provement for our facility. Staff communication, goal setting, 12. Hertzog D, Waybill P. Complications and controversies and application of a process established a staff culture that is associated with peripherally inserted central catheters. J Infus continually striving for better outcomes. The steps for defin- Nurs. 2008;31:159-163. ing, measuring, analyzing, improving/implementing, and 13. Bartock L. An evidence-based systematic review of literature controlling the system identified areas of deficiency for CVAD for the reduction of PICC line occlusions. J Assoc Vasc occlusion management, flushing, and supply use. 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